Segmented skirted surgical mesh

ABSTRACT

A segmented skirted surgical mesh for use in reconstructing a soft tissue defect, the segmented skirted surgical mesh comprising:
         a base layer of surgical mesh, the base layer of surgical mesh comprising an outer edge; and   a segmented continuous skirt of surgical mesh comprising an outer edge and an inner edge which defines a central opening, the segmented continuous skirt of surgical mesh being secured to the base layer of surgical mesh at the outer edge of the continuous skirt of surgical mesh, and the segmented continuous skirt of surgical mesh comprising a plurality of slits formed in the segmented continuous skirt of surgical mesh, wherein the plurality of slits extend outwardly from the inner edge of the segmented continuous skirt of surgical mesh, whereby to form a plurality of flaps of surgical mesh in the segmented continuous skirt of surgical mesh, such that at least one of the flaps of surgical mesh can be lifted away from the base layer of surgical mesh and secured to soft tissue without causing distortion of the base layer of surgical mesh.

REFERENCE TO PENDING PRIOR PATENT APPLICATIONS

This patent application is a continuation of pending prior U.S. patentapplication Ser. No. 14/325,969, filed Jul. 8, 2014 by BG MEDICAL, LLCet al. for SEGMENTED SKIRTED SURGICAL MESH, which patent application inturn:

(i) claims benefit of prior U.S. Provisional Patent Application Ser. No.61/843,771, filed Jul. 8, 2013 by BG Medical, LLC and John W. Huelskampet al. for SEGMENTED SKIRTED HERNIA MESH; and

(ii) claims benefit of prior U.S. Provisional Patent Application Ser.No. 61/845,191, filed Jul. 11, 2013 by BG Medical, LLC and John W.Huelskamp et al. for SEGMENTED SKIRTED HERNIA MESH.

The three (3) above-identified patent applications are herebyincorporated herein by reference.

FIELD OF THE INVENTION

This invention relates to medical procedures and apparatus in general,and more particularly to medical procedures and apparatus for repairingsoft tissue defects such as abdominal hernias and the like.

BACKGROUND OF THE INVENTION

In the reconstruction of soft tissue defects in humans and animals, suchas in abdominal hernia repairs, surgical mesh is often used to reinforcethe soft tissue defect so as to facilitate healing and to preventsubsequent defect recurrence. More particularly, when performing aclosure of a soft tissue defect in an anatomical wall (e.g., to repairan abdominal hernia), it is common to secure a surgical mesh to the softtissue at the edge of the soft tissue defect, with some overlap betweenthe surgical mesh and the soft tissue, so as to increase the healedstrength of the surgical repair. The surgical mesh is typically securedto the soft tissue adjacent to the soft tissue defect with suture ortacks.

In practice, and looking now at FIGS. 1-3, in open procedures the softtissue reconstruction is typically carried out using a “skirted”surgical mesh 5. Skirted surgical mesh 5 generally comprises a baselayer 10 of surgical mesh terminating in an outer edge 12, and acontinuous “skirt” or rim 15 of surgical mesh terminating in an outeredge 17 and an inner edge 18 which defines a central opening 19.Continuous skirt or rim 15 overlies the outer portion of base layer 10(e.g., so that outer edge 17 of continuous skirt or rim 15 issubstantially aligned with outer edge 12 of base layer 10), andcontinuous skirt or rim 15 is secured to base layer 10 only at oradjacent to outer edge 17 of continuous skirt or rim 15, such that theinner portions of continuous skirt or rim 15 (i.e., the portionsadjacent to inner edge 18) can be lifted away from base layer 10 whendesired. As a result, continuous skirt or rim 15 provides an easilyaccessed section of surgical mesh which facilitates fixation of skirtedsurgical mesh 5 to the soft tissue, i.e., by fixing continuous skirt orrim 15 of skirted surgical mesh 5 to the edges of the soft tissue defectusing conventional suture or tack fixation. By providing skirtedsurgical mesh 5 with the continuous skirt or rim 15 of mesh material,when skirted surgical mesh 5 is being secured to the soft tissue, thesharp ends of the fixation elements (e.g., the suture needle or tack)are isolated from the delicate internal organs of the patient by baselayer 10, whereby to prevent inadvertent damage to the delicate internalorgans of the patient.

However, it has been found that when pulling up on continuous skirt orrim 15 of skirted surgical mesh 5 (e.g., for suturing and/or tacking),this pulling up of the continuous skirt or rim 15 can cause base layer10 to distort significantly (e.g., to transform from a smooth planarconfiguration to a curved configuration, such as is shown in FIG. 4).Such distortion in base layer 10 of skirted surgical mesh 5 can make itdifficult to provide a flat, symmetrical repair which is smooth andcomfortable for the patient. More particularly, the configurations ofsurgical mesh used in these types of soft tissue repairs (e.g., thehernia meshes used in abdominal hernia repairs) are normally circular oroval in shape (FIGS. 2-4 show exemplary surgical meshes which are ovalin shape) and can possess very tight radii, particularly at thelongitudinal ends 25 of oval skirted surgical meshes 5 (see FIGS. 2 and4). As the radii of continuous skirt or rim 15 of skirted surgical mesh5 becomes tighter, the effect of “pulling up” on the continuous skirt orrim 15 of skirted surgical mesh 5 (e.g., with graspers 30, FIG. 4) isincreasingly distorting to base layer 10 of skirted surgical mesh 5.

Efforts have been made to reduce this distortion of base layer 10 ofskirted surgical mesh 5 when pulling up on continuous skirt or rim 15 ofskirted surgical mesh 5.

In one such effort, and looking now at FIG. 5, the inner edge 18 ofcontinuous skirt or rim 15 is scalloped (i.e., a portion of inner edge18 of continuous skirt or rim 15 is recessed, such as is shown in FIG. 5at 40, from the remainder of inner edge 18 in an effort to minimize thedistortion of base layer 10 of skirted surgical mesh 5 when pulling upon continuous skirt or rim 15 of skirted surgical mesh 5. Unfortunately,in practice, this approach has proven to be of limited benefit.

In another such effort, and looking now at FIG. 6, a surgical mesh 45 isprovided which comprises a base layer 50 of surgical mesh which iscompletely covered with a top layer 55 of surgical mesh, with top layer55 being secured to base layer 50 about the outer edge(s) 60 of the twolayers, and with top layer 55 being bifurcated at 65 so as to providetwo separate pockets of surgical mesh. Then, during use, a first half oftop layer 55 of surgical mesh 45 is pulled upward for fixation (e.g., bygripping the first half of top layer 55 with graspers 30 at thebifurcation line 65) and then the second half of the top layer 55 ofsurgical mesh 45 is pulled upward for fixation (e.g., by gripping thatsecond half of top layer 55 with graspers 30 at bifurcation line 65).Unfortunately, this construction still suffers from distortion of baselayer 50 when one or both halves of top layer 55 of surgical mesh 45 isdrawn upward for fixation.

Thus there is a need for a novel surgical mesh which provides a skirt orrim of surgical mesh about the outer perimeter of a base layer ofsurgical mesh but which allows the skirt or rim of surgical mesh to bepulled upward without distorting the smooth planar configuration of thebase layer of surgical mesh.

SUMMARY OF THE INVENTION

The present invention comprises the provision and use of a novelsurgical mesh which provides a skirt or rim of surgical mesh about theouter perimeter of a base layer of surgical mesh but which allows theskirt or rim of surgical mesh to be pulled upward without distorting thesmooth planar configuration of the base layer of surgical mesh.

In one preferred form of the invention, there is provided a segmentedskirted surgical mesh for use in reconstructing a soft tissue defect,the segmented skirted surgical mesh comprising:

a base layer of surgical mesh, said base layer of surgical meshcomprising an outer edge; and

a segmented continuous skirt of surgical mesh comprising an outer edgeand an inner edge which defines a central opening, said segmentedcontinuous skirt of surgical mesh being secured to said base layer ofsurgical mesh at said outer edge of said segmented continuous skirt ofsurgical mesh, and said segmented continuous skirt of surgical meshcomprising a plurality of slits formed in said segmented continuousskirt of surgical mesh, wherein said plurality of slits extend outwardlyfrom said inner edge of said segmented continuous skirt of surgicalmesh, whereby to form a plurality of flaps of surgical mesh in saidsegmented continuous skirt of surgical mesh, such that at least one ofsaid flaps of surgical mesh can be lifted away from said base layer ofsurgical mesh and secured to soft tissue without causing distortion ofsaid base layer of surgical mesh.

In another preferred form of the invention, there is provided a methodfor reconstructing a soft tissue defect, the method comprising:

providing a segmented skirted surgical mesh comprising:

-   -   a base layer of surgical mesh, said base layer of surgical mesh        comprising an outer edge; and    -   a segmented continuous skirt of surgical mesh comprising an        outer edge and an inner edge which defines a central opening,        said segmented continuous skirt of surgical mesh being secured        to said base layer of surgical mesh at said outer edge of said        segmented continuous skirt of surgical mesh, and said segmented        continuous skirt of surgical mesh comprising a plurality of        slits formed in said segmented continuous skirt of surgical        mesh, wherein said plurality of slits extend outwardly from said        inner edge of said segmented continuous skirt of surgical mesh,        whereby to form a plurality of flaps of surgical mesh in said        segmented continuous skirt of surgical mesh, such that at least        one of said flaps of surgical mesh can be lifted away from said        base layer of surgical mesh and secured to soft tissue without        causing distortion of said base layer of surgical mesh;

positioning said segmented skirted surgical mesh adjacent to a softtissue defect; and

lifting at least one of said flaps of surgical mesh away from said baselayer of surgical mesh and securing said at least one flap of surgicalmesh to soft tissue without causing distortion of said base layer ofsurgical mesh.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIG. 1 is a schematic view showing a soft tissue defect beingreconstructed using a surgical mesh;

FIGS. 2 and 3 are schematic views showing a prior art skirted surgicalmesh in greater detail;

FIG. 4 is a schematic view showing the prior art skirted surgical meshof FIGS. 2 and 3 becoming distorted as the continuous skirt or rim ofthe skirted surgical mesh is lifted away from the base layer of theskirted surgical mesh;

FIG. 5 is a schematic view showing a prior art skirted surgical meshwherein the inner edge of the continuous skirt or rim of the surgicalmesh is scalloped in an effort to minimize distortion of the base layerof the skirted surgical mesh as the continuous skirt or rim of theskirted surgical mesh is lifted away from the base layer of the skirtedsurgical mesh;

FIG. 6 is a schematic view showing a prior art surgical mesh whichcomprises a base layer of surgical mesh which is completely covered witha top layer of surgical mesh, with the top layer of surgical mesh beingsecured to the base layer of surgical mesh about the outer edges of thetwo layers, and with the top layer of surgical mesh being bifurcated soas to provide two separate pockets of surgical mesh;

FIGS. 7-10 are schematic views showing a novel segmented skirtedsurgical mesh formed in accordance with the present invention;

FIGS. 11 and 12 are schematic views showing another novel segmentedskirted surgical mesh formed in accordance with the present invention;and

FIGS. 13-15 are schematic views showing another novel segmented skirtedsurgical mesh formed in accordance with the present invention; and

FIGS. 16-18 are schematic views showing another novel segmented skirtedsurgical mesh formed in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention comprises the provision and use of a novelsurgical mesh which provides a skirt or rim of surgical mesh about theouter perimeter of a base layer of surgical mesh but which allows theskirt or rim of surgical mesh to be pulled upward without distorting thesmooth planar configuration of the base layer of surgical mesh.

More particularly, and looking now at FIGS. 7-10, the present inventioncomprises the provision and use of a novel segmented skirted surgicalmesh 105. Novel segmented skirted surgical mesh 105 comprises a baselayer 110 of surgical mesh terminating in an outer edge 112, and asegmented continuous skirt or rim 115 of surgical mesh terminating in anouter edge 117 and an inner edge 118 which defines a central opening119. Segmented continuous skirt or rim 115 overlies the outer portion ofbase layer 110 (e.g., so that outer edge 117 of segmented continuousskirt or rim 115 is substantially aligned with outer edge 112 of baselayer 110), and segmented continuous skirt or rim 115 is secured to baselayer 110 only at or adjacent to outer edge 117 of segmented continuousskirt or rim 115, such that the inner portions of segmented continuousskirt or rim 115 (i.e., the portions adjacent to inner edge 118) can belifted away from base layer 110 when desired.

The segmented continuous skirt or rim 115 of surgical mesh is segmentedby providing a plurality of breaks or cuts or slits 122 in thecontinuity of segmented continuous skirt or rim 115 of surgical mesh105, whereby to form a plurality of segments or flaps 123A, 123B, 123C,etc. of the segmented continuous skirt or rim 115. In one preferred formof the invention, there are at least three breaks or cuts or slits 122in the continuity of segmented continuous skirt or rim 115 of surgicalmesh 105, whereby to form at least three segments or flaps 123A, 123B,123C, etc.

Each of the segments or flaps 123A, 123B, 123C, etc. of segmentedcontinuous skirt or rim 115 provides an easily accessed section ofsurgical mesh which facilitates fixation of segmented skirted surgicalmesh 105 to the soft tissue, i.e., by fixing the various segments orflaps 123A, 123B, 123C, etc. of segmented continuous skirt or rim 115 tothe edges of the soft tissue defect using conventional suture or tackfixation. By providing segmented skirted surgical mesh 5 with thesegmented continuous skirt or rim 115 of surgical mesh, when segmentedskirted surgical mesh 105 is being secured to the soft tissue, the sharpends of the fixation elements (e.g., the suture needle or tack) areisolated from the delicate internal organs of the patient by base layer110 of segmented skirted surgical mesh 105, whereby to preventinadvertent damage to the delicate internal organs of the patient. Atthe same time, and significantly, by providing a segmented continuousskirt or rim 115 of surgical mesh, where the segmented continuous skirtor rim 115 is segmented (through the provision of breaks or cuts orslits 122) into a plurality of segments or flaps 123A, 123B, 123C, etc.,distortion of base layer 110 of segmented skirted surgical mesh 105 canbe reduced or eliminated when segmented continuous skirt or rim 115 ispulled upward, since then only the surgical mesh of a particular segmentor flap 123A, 123B, 123C, etc. is pulled upward—the remainder of thesegments or flaps 123A, 123B, 123C, etc. of the segmented continuousskirt or rim 115 are unaffected, which results in reduced distortion ofbase layer 110 of segmented skirted surgical mesh 105.

By way of example but not limitation, having three or four evenly-spacedbreaks or cuts or slits 122 in segmented continuous skirt or rim 115 ofa small oval or circular segmented skirted surgical mesh 105 keeps baselayer 110 of segmented skirted surgical mesh 105 substantially flat evenwhen some or all of segments or flaps 123A, 123B, 123C, etc. of thesegmented continuous skirt or rim 115 is lifted up from base layer 110of segmented skirted surgical mesh 105 (FIGS. 7-10), since then only thesurgical mesh of a particular segment or flap 123A, 123B, 123C, etc. ispulled upward—the remainder of the segments or flaps 123A, 123B, 123C,etc. are unaffected, which results in reduced distortion of base layer110 of segmented skirted surgical mesh 105.

In larger constructions, an oval configuration (FIGS. 7-10) is typicallyused, inasmuch as defects in a body wall cavity (e.g., an abdominalhernia) are typically oblong in shape (due to the stress orientation inthe soft tissue). These oval configurations have opposing tight endradii 125 which benefit even more than circular configurations byproviding breaks or cuts or slits 122 in segmented continuous skirt orrim 115.

FIGS. 11 and 12 show a segmented skirted surgical mesh 105 having acircular configuration. Note that the segmented continuous skirt or rim115 of segmented skirted surgical mesh 105 of FIGS. 11 and 12 has threebreaks or cuts or slits 122, whereby to provide three segments or flaps123A, 123B and 123C.

The breaks or cuts or slits 122 in segmented continuous skirt or rim 115of segmented skirted surgical mesh 105 are preferably accomplished bycutting through segmented continuous skirt or rim 115, preferablystarting at inner edge 118 of segmented continuous skirt or rim 115 andextending radially outwardly, and preferably terminating just short ofthe outer edge 117 of segmented continuous skirt or rim 115. In onepreferred embodiment, breaks or cuts or slits 122 extend at an angle of90 degrees to the adjacent inner edge 118 of segmented continuous skirtor rim 115. Alternatively, the breaks or cuts or slits 122 in segmentedcontinuous skirt or rim 115 may be made at varying angles to inner edge118 of segmented continuous skirt or rim 115 so as to further minimizedistortion in base layer 110 of segmented skirted surgical mesh 105 whensegments or flaps 123A, 123B, 123C, etc. are subjected to lifting awayfrom base layer 110.

FIGS. 13-15 show another segmented skirted surgical mesh formed inaccordance with the present invention. And FIGS. 16-18 show stillanother segmented skirted surgical mesh formed in accordance with thepresent invention. Note that with the segmented skirted surgical meshesof FIGS. 13-15 and FIGS. 16-18, segmented continuous skirt or rim 115 ismodified so as to provide different sized central openings 119.

The breaks or cuts or slits 122 in segmented continuous skirt or rim 115preferably extend almost all the way to outer edge 117 of segmentedcontinuous skirt or rim 115, although the breaks or cuts or slits mayalso extend all the way to outer edge 117 if desired, or may terminateintermediate of segmented continuous skirt or rim 115 if desired.

The number of cuts or breaks or slits 122 formed in segmented continuousskirt or rim 115 of segmented skirted surgical mesh 105, and theplacement of those breaks or cuts or slits 122, may be optimized so asto (i) minimize distortion of base layer 110 when a segment or flap123A, 123B, 123C, etc. is pulled upward, and (ii) minimize the overallnumber of segments or flaps 123A, 123B, 123C, etc. that the segmentedcontinuous skirt or rim 115 is divided into (since “too many segments orflaps” has the potential to complicate the fixation process for thesurgeon). In practice, it is generally preferred to make three or fourcuts or breaks or slits 122 in the segmented continuous skirt or rim 115of segmented skirted surgical mesh 105, whereby to provide three or foursegments or flaps 123A, 123B, 123C, etc. in segmented continuous skirtor rim 115 of segmented skirted surgical mesh 105, since providing lessthan three cuts or breaks or slits 122 in segmented continuous skirt orrim 115 makes it difficult to lift the segments or flaps of continuoussegmented skirt or rim 115 away from base layer 110 without distortingbase layer 110.

It should also be appreciated that, if desired, outer edge 117 ofsegmented continuous skirt or rim 115 could terminate inboard of outeredge 112 of base layer 110. Alternatively, outer edge 117 of segmentedcontinuous skirt or rim 115 could overlap outer edge 112 of base layer110 (e.g., outer edge 117 of segmented continuous skirt or rim 115 couldbe folded over edge 112 of base layer 110).

By minimizing the distortion of base layer 110 of segmented skirtedsurgical mesh 105 when one or more of the segments or flaps 123A, 123B,123C, etc. of segmented continuous skirt or rim 115 is lifted up duringfixation, the fixation itself is facilitated, i.e., the fixation willtake less time and the final repair geometry is controlled so that thereare no gathered areas that might lead to potential sites of discomfortfor the patient. Thus, the segmented skirted surgical mesh of thepresent invention benefits both the surgeon (through facilitatedfixation) and the patient (by producing a more cosmetic and comfortablereconstruction).

MODIFICATIONS OF THE PREFERRED EMBODIMENTS

It should be understood that many additional changes in the details,materials, steps and arrangements of parts, which have been hereindescribed and illustrated in order to explain the nature of the presentinvention, may be made by those skilled in the art while still remainingwithin the principles and scope of the invention.

What is claimed is:
 1. A method for reconstructing a soft tissue defect,said method comprising: providing a segmented skirted surgical meshcomprising: a base layer of surgical mesh, said base layer of surgicalmesh comprising an outer edge; and a segmented continuous skirt ofsurgical mesh comprising an outer edge and an inner edge which defines acentral opening, said outer edge being disposed at a distance from saidinner edge, said segmented continuous skirt of surgical mesh beingsecured to said base layer of surgical mesh at said outer edge of saidsegmented continuous skirt of surgical mesh, and said segmentedcontinuous skirt of surgical mesh comprising a plurality of slits formedin said segmented continuous skirt of surgical mesh, wherein saidplurality of slits extend outwardly from said inner edge of saidsegmented continuous skirt of surgical mesh, with said plurality ofslits extending at least half of said distance that said outer edge isdisposed from said inner edge, whereby to form a plurality of flaps ofsurgical mesh in said segmented continuous skirt of surgical mesh, suchthat at least one of said flaps of surgical mesh can be lifted away fromsaid base layer of surgical mesh and secured to soft tissue withoutcausing distortion of said base layer of surgical mesh; positioning saidsegmented skirted surgical mesh adjacent to a soft tissue defect; andlifting at least one of said flaps of surgical mesh away from said baselayer of surgical mesh and securing said at least one flap of surgicalmesh to soft tissue without causing distortion of said base layer ofsurgical mesh.
 2. A method according to claim 1 wherein said outer edgeof said base layer has an oval configuration.
 3. A method according toclaim 1 wherein said outer edge of said base layer has a circularconfiguration.
 4. A method according to claim 1 wherein said pluralityof slits comprises three slits formed in said segmented continuous skirtof surgical mesh.
 5. A method according to claim 1 wherein saidplurality of slits comprises four slits formed in said segmentedcontinuous skirt of surgical mesh.
 6. A method according to claim 1wherein each of said plurality of slits extends at an angle of 90degrees to the said inner edge of said segmented continuous skirt.
 7. Amethod according to claim 1 wherein each of said plurality of slitsextends at an angle of other than 90 degrees to the said inner edge ofsaid segmented continuous skirt of surgical mesh.